MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926224400

Device Problems Migration or Expulsion of Device (1395); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

It was reported that stent movement on balloon occurred.A 4.00 x 24 synergy¿ stent was selected however during preparation of the device, it was noted that the stent was slipping from the stent delivery system balloon while still outside the patient's body.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

Device is a combination product.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The crimped stent was detached from balloon and was not returned with device for analysis.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were evident on the entire length of the balloon wall indicating overall crimp contact between the coated stent and balloon.The stent crimp force, the crimp temperature and the crimp duration for the device all are within the specified range.Reviewing these specified parameters against the batch records for the crimped unit, there are no anomalies evident.The product stent protector was not returned for analysis with the device.Based on the specified stent protector profile and the recorded crimped stent profile, there is no issues to note with the interaction between the 2 components.The bumper tip of the device showed no signs of damage.A visual and tactile examination found no issues with the hypotube shaft profile.A visual and tactile examination found no issues with the mid-shaft or inner/outer shafts.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that stent movement on balloon occurred.A 4.00 x 24 synergy stent was selected however during preparation of the device, it was noted that the stent was slipping from the stent delivery system balloon while still outside the patient's body.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.This product is only ous approved but it is similar to an approved us device.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4964356
• MDR Text Key: 6194404
• Report Number: 2134265-2015-05033
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2016
• Device Model Number: H7493926224400
• Device Lot Number: 17824142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1